Senior Sterility Assurance Specialist

2 days ago


Concord, North Carolina, United States Eli Lilly Full time

Estimated annual salary: $120,000 - $160,000

About Eli Lilly

We are a global healthcare leader committed to discovering and developing innovative medicines that improve people's lives. Our mission is to unite caring with discovery to make life better for people around the world.

Job Summary

We are seeking a Senior Sterility Assurance Specialist to join our team in Indianapolis, Indiana. As a key member of our Parenteral Process Team, you will assist in the development and implementation of sterility assurance programs and provide technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.

Responsibilities:
  • Develop and implement a technical agenda for sterility assurance programs
  • Provide technical leadership for the Parenteral Process Team
  • Lead or provide technical oversight for activities related to sterility assurance programs
  • Apply sterility assurance risk management to evaluate manufacturing processes and associated controls
  • Analyze microbial and manufacturing data to identify trends and opportunities for continuous improvements
Requirements:
  • Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
  • 5+ years of experience in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related department)
  • Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing
Benefits:
  • A competitive salary range of $120,000 - $160,000 per year
  • A comprehensive benefits package, including medical, dental, and vision insurance
  • A 401(k) plan with company match
  • Generous paid time off and holidays
About Us

Eli Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status. We offer a diverse and inclusive work environment and are committed to attracting and retaining talented individuals from all backgrounds.



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